Abstract
RELEVANCE: Non-surgical contraceptives or sterilants need regulatory approval to be sold for that use. This approval process gives veterinarians the information required to assess the benefits and risks of each product, and to provide comprehensive information on the required dose, method and duration of use, safety and effectiveness. AIM: This article reviews the information that must be developed and provided to regulatory agencies worldwide, with a focus on the European Union and the United States, in order to achieve regulatory approval. PROCESSES: The main components of developing a drug include developing extensive information on the safety and effectiveness of the product, and also the safety to the environment and to humans handling and administering the drug. Most importantly, a robust method of manufacturing both the drug itself and the formulated drug product (pill, liquid implant or injection) must be developed to assure quality and consistency in each batch. This information is then compiled and submitted to regulatory agencies; in the United States, this includes the Food and Drug Administration, the United States Department of Agriculture and the Environmental Protection Agency, and, in Europe, the European Medicines Agency. CHALLENGES: Because of the unique nature of non-surgical contraceptives for use in cats and dogs, particularly the desire to have these products last over multiple years, there are special challenges to their regulatory approval that are discussed in this review.